Adjustable bone plates

ABSTRACT

Bone plates having an adjustable joint, and methods of using the bone plates to fix bones.

CROSS-REFERENCES TO PRIORITY APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/652,185, filed Oct. 15, 2012.

U.S. patent application Ser. No. 13/652,185, in turn, is a continuationof U.S. patent application Ser. No. 12/768,508, filed Apr. 27, 2010, nowabandoned, and is a continuation-in-part of the following U.S. patentapplication Ser. No. 13/246,687, filed Sep. 27, 2011, now U.S. Pat. No.8,518,090; Ser. No. 13/246,690, filed Sep. 27, 2011, now U.S. Pat. No.8,523,919; Ser. No. 13/246,684, filed Sep. 27, 2011, now U.S. Pat. No.8,425,575; and Ser. No. 13/187,395, filed Jul. 20, 2011, now abandoned.

U.S. patent application Ser. No. 12/768,508, in turn, is acontinuation-in-part of the following U.S. patent application Ser. No.11/504,223, filed Aug. 14, 2006, now U.S. Pat. No. 7,704,251; Ser. No.11/637,626, filed Dec. 11, 2006, now U.S. Pat. No. 7,717,945; Ser. No.11/929,026, filed Oct. 30, 2007, now U.S. Pat. No. 7,955,388; Ser. No.12/175,223, filed Jul. 17, 2008, now U.S. Pat. No. 8,475,504; and Ser.No. 12/176,913, filed Jul. 21, 2008, now U.S. Pat. No. 8,231,627.

U.S. patent application Ser. No. 11/504,223, in turn, is a continuationof U.S. patent application Ser. No. 10/716,719, filed Nov. 19, 2003, nowU.S. Pat. No. 7,090,676, which, in turn, is based upon and claims thebenefit under 35 U.S.C. §119(e) of the following U.S. provisional patentapplication Ser. No. 60/427,908, filed Nov. 19, 2002; and Ser. No.60/512,136, filed Oct. 17, 2003.

U.S. patent application Ser. No. 11/637,626, in turn, is acontinuation-in-part of the following U.S. patent application Ser. No.10/625,503, filed Jul. 22, 2003, now U.S. Pat. No. 7,537,603; Ser. No.10/712,202, filed Nov. 12, 2003, now abandoned; Ser. No. 10/717,015,filed Nov. 19, 2003, now U.S. Pat. No. 7,537,604; Ser. No. 10/717,399,filed Nov. 19, 2003, now U.S. Pat. No. 7,326,212; Ser. No. 10/717,401,filed Nov. 19, 2003, now U.S. Pat. No. 7,153,309; Ser. No. 10/717,402,filed Nov. 19, 2003, now U.S. Pat. No. 7,189,237; Ser. No. 10/734,017,filed Dec. 10, 2003, now U.S. Pat. No. 7,147,640; Ser. No. 10/873,522,filed Jun. 21, 2004, now U.S. Pat. No. 7,537,596; Ser. No. 10/993,205,filed Nov. 18, 2004, now U.S. Pat. No. 7,235,079; Ser. No. 11/050,342,filed Feb. 2, 2005, now abandoned; Ser. No. 11/109,984, filed Apr. 19,2005, now U.S. Pat. No. 7,578,825; Ser. No. 11/109,985, filed Apr. 19,2005, now abandoned; Ser. No. 11/112,858, filed Apr. 22, 2005, nowabandoned; Ser. No. 11/273,811, filed Nov. 14, 2005, now abandoned; Ser.No. 11/274,597, filed Nov. 14, 2005, now U.S. Pat. No. 7,927,332; Ser.No. 11/330,802, filed Jan. 11, 2006, now abandoned; Ser. No. 11/449,554,filed Jun. 7, 2006, now abandoned; Ser. No. 11/486,959, filed Jul. 13,2006, now U.S. Pat. No. 7,857,836; Ser. No. 11/504,223, filed Aug. 14,2006, now U.S. Pat. No. 7,704,251; Ser. No. 11/550,255, filed Oct. 17,2006, now U.S. Pat. No. 8,231,662; and Ser. No. 11/585,378, filed Oct.23, 2006, now U.S. Pat. No. 7,914,532.

U.S. patent application Ser. No. 10/625,503, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of the following U.S.provisional patent application Ser. No. 60/398,075, filed Jul. 22, 2002;and Ser. No. 60/484,262, filed Jun. 30, 2003.

U.S. patent application Ser. No. 10/717,015, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/512,323, filed Oct. 17, 2003.

U.S. patent application Ser. No. 10/717,399, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of the following U.S.provisional patent application Ser. No. 60/427,908, filed Nov. 19, 2002;and Ser. No. 60/512,136, filed Oct. 17, 2003.

U.S. patent application Ser. No. 10/717,401, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of the following U.S.provisional patent application Ser. No. 60/427,910, filed Nov. 19, 2002;and Ser. No. 60/512,322, filed Oct. 17, 2003.

U.S. patent application Ser. No. 10/717,402, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of the following U.S.provisional patent application Ser. No. 60/427,908, filed Nov. 19, 2002;and Ser. No. 60/512,136, filed Oct. 17, 2003.

U.S. patent application Ser. No. 10/734,017, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/454,217, filed Mar. 12, 2003.

U.S. patent application Ser. No. 10/873,522, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/480,529, filed Jun. 20, 2003.

U.S. patent application Ser. No. 10/993,205, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/541,414, filed Feb. 2, 2004.

U.S. patent application Ser. No. 11/109,984, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/563,860, filed Apr. 19, 2004.

U.S. patent application Ser. No. 11/109,985, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/563,767, filed Apr. 19, 2004.

U.S. patent application Ser. No. 11/112,858, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/564,853, filed Apr. 22, 2004.

U.S. patent application Ser. No. 11/273,811, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/627,297, filed Nov. 12, 2004.

U.S. patent application Ser. No. 11/274,597, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/627,721, filed Nov. 12, 2004.

U.S. patent application Ser. No. 11/449,554, in turn, is a continuationof U.S. patent application Ser. No. 10/873,522, which, in turn, is basedupon and claims the benefit under 35 U.S.C. §119(e) of U.S. ProvisionalPatent Application Ser. No. 60/480,529, filed Jun. 20, 2003.

U.S. patent application Ser. No. 11/486,959, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/699,277, filed Jul. 13, 2005.

U.S. patent application Ser. No. 11/585,378, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/729,373, filed Oct. 21, 2005.

U.S. patent application Ser. No. 11/929,026, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/856,128, filed Nov. 1, 2006.

U.S. patent application Ser. No. 12/175,223, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/961,317, filed Jul. 19, 2007.

U.S. patent application Ser. No. 12/176,913, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 60/961,317, filed Jul. 19, 2007.

U.S. patent application Ser. No. 13/246,687, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 61/390,121, filed Oct. 5, 2010.

U.S. patent application Ser. No. 13/246,690, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 61/386,921, filed Sep. 27, 2010.

U.S. patent application Ser. No. 13/246,684, in turn, is based upon andclaims the benefit under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication Ser. No. 61/386,925, filed Sep. 27, 2010.

Each of these priority patent applications is incorporated herein byreference in its entirety for all purposes.

FIELD OF THE INVENTION

The invention relates to bone plates. More specifically, the inventionrelates to bone plates having an adjustable joint.

BACKGROUND

The human skeleton is composed of 206 individual bones that perform avariety of important functions, including support, movement, protection,storage of minerals, and formation of blood cells. To ensure that theskeleton retains its ability to perform these functions and to reducepain and disfigurement, bones that become damaged should be repairedpromptly and properly. Typically, a fractured or cut bone is treatedusing a fixation device, which reinforces the bone and keeps it alignedduring healing. Fixation devices may include external fixation devices(such as casts and fixators) and/or internal fixation devices (such asbone plates, nails, and bone screws), among others.

Bone plates are sturdy internal devices, usually made of metal, thatmount directly to the bone adjacent the fracture (or osteotomy). To usea bone plate to repair a discontinuity of a bone, a surgeon typically(1) selects an appropriate plate, (2) reduces the discontinuity (e.g.,sets the fracture), and (3) fastens the plate to bone portions disposedon opposite sides of the discontinuity using suitable fasteners, such asscrews and/or wires, so that the bone portions are fixed in position.

Despite direct access to the bone portions when applying a bone plate,the surgeon may have difficulty fixing the bone portions with thecorrect alignment. For example, one or more of the bone portions may berelatively small and/or displaced from the bone plate. As a specificexample, in fixation of fractures of the distal radius, a distal boneportion(s) may be difficult to position properly. More generally, duringattachment of any bone plate, fasteners may be misplaced or misdirectedso that bone portions move away from a desired positioning as thefasteners are tightened. Accordingly, the relative position of boneportions may need to be adjusted after the bone plate has been securedto a bone to achieve proper reduction of a fracture.

SUMMARY

The invention provides bone plates having an adjustable joint, andmethods of using the bone plates to fix bones.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a series of views of a fractured bone showing its fracturebeing reduced and the bone being fixed with a pivotable bone plate, inaccordance with the present teachings.

FIG. 2 is a lateral view of the bones of the right hand and distalforearm in which the radius has suffered a Colles' fracture, displacingand angulating a distal fragment of the radius dorsally.

FIG. 3 is a sectional lateral-medial view of the fractured radius ofFIG. 2, with a first example of a bone plate affixed to the volarsurface of the fractured radius and configured for bending and twistingmovement within the bone plate, in accordance with the presentteachings.

FIG. 4 is a volar view of the fractured radius and bone plate of FIG. 3.

FIG. 5 is a partially exploded view of the bone plate of FIGS. 3 and 4as seen from a position generally above the outer surface of the boneplate, in the absence of the distal radius and in the presence of bonescrews.

FIG. 6 is a fragmentary sectional view of the bone plate of FIG. 5,viewed generally along line 6-6 of FIG. 5.

FIG. 7 is an exploded view of a second example of a bone plate forfixing a fractured distal radius, in which axial and transverse portionsof the bone plate can pivot and slide in relation to each other, inaccordance with the present teachings.

FIG. 8 is a sectional view of the bone plate of FIG. 7 when assembled,viewed generally along line 8-8 of FIG. 7.

FIG. 9 is an exploded view of a third example of a bone plate for fixinga fractured distal radius, in which axial and transverse portions of thebone plate can pivot relative to one another about spaced orthogonalaxes, in accordance with the present teachings.

FIG. 10 is an exploded view of a fourth example of a bone plate forfixing a fractured distal radius, in which axial and transverse portionsof the bone plate can pivot about one axis and slide translationallyrelative to one another, in accordance with the present teachings.

FIG. 11 is a view of a fifth example of a bone plate for fixing afractured distal radius, in which axial and transverse portions of thebone plate can pivot about a normal axis and slide along a curved path,in accordance with the present teachings.

FIG. 12 is a fragmentary sectional view of the bone plate of FIG. 11,viewed generally along line 12-12 of FIG. 11.

FIG. 13 is a sectional view of the bone plate of FIG. 11, viewedgenerally along line 13-13 of FIG. 11.

FIG. 14 is an exploded view of the bone plate of FIG. 11.

FIG. 15 is an exploded view of a sixth example of a bone plate forfixing a fractured distal radius, with portions of the bone plate beingpivotable and having reference marks to indicate the angular dispositionof the plate portions, in accordance with the present teachings.

FIG. 16 is a fragmentary plan view of the bone plate of FIG. 15 in anassembled configuration, showing further aspects of the reference marksand illustrating use of the reference marks to measure the angulardisposition of the plate portions.

FIG. 17 is a plan view of a seventh example of a bone plate for fixing afractured distal radius, in which portions of the bone plate can pivotrelative to each other about a plurality of axes, in accordance with thepresent teachings.

FIG. 18 is an exploded view of the bone plate of FIG. 17.

FIG. 19 is a side elevation view of the bone plate of FIG. 17 positionedon the volar surface of the distal radius for fixation of a distalradius fracture, in accordance with the present teachings.

DETAILED DESCRIPTION

The invention provides bone plates having an adjustable joint, andmethods of using the bone plates to fix bones.

The bone plates each may include a plurality of plate members connectedby an adjustable (pivotable and/or translational) joint. The adjustablejoint may be configured so that the shape and/or extent of the boneplate may be changed by adjusting the angular disposition of the platemembers. The angular disposition may be adjusted by pivotal movement ofa plate member about one axis or about a plurality of axes, and then theangular disposition may be fixed (locked). Each plate member may defineone or more openings. The plate members may be configured to be securedto different regions of one bone or secured to different bones usingfasteners placed in the openings.

The shapes and/or extent of the bone plates may be adjusted before,during, and/or after securing the bone plates to bone. When adjustedafter attachment, movement of the plate members may change the relativedisposition of attached bone portions, enabling a surgeon to improve thealignment and/or spacing of fractured or osteotomized bones, amongothers. As a result, reduction, fixation, and/or healing may befacilitated.

Bone plates having adjustable joints, as described herein, may beattached to or otherwise associated with bone using any suitable methodor procedure. For example, a surgeon may (1) select an appropriateplate, (2) reduce (set) any fracture(s) or other discontinuities in thebone (at least partially), (3) fasten the plate to opposite sides of thefracture using suitable fasteners, such as screws and/or wires, (4)adjust the shape of the plate to adjust reduction of the fracture, and(5) fix the shape, so that attached portions of the bone are fixed inposition. These steps may be performed manually and/or mechanically, forexample, using a guide system as described in the following patentapplication, which is incorporated herein by reference: U.S. patentapplication Ser. No. 10/717,401, filed Nov. 19, 2003.

FIG. 1 shows a series of views of a fractured bone 20 with its fracture21 being reduced and the bone being fixed with a pivotable bone plate22.

FIG. 1A shows bone plate 22 secured to bone 20 without completereduction of fracture 21. Bone plate 22 may include a first plate member24 and a second plate member 26. Each of the plate members may defineone or more openings 28 through which bone screws 30 (or otherfasteners) may be placed into (or otherwise associated with) bone 20 tosecure the plate members to the bone. The plate members may be securedto different portions or pieces 32, 34 of bone 20 disposed on opposingsides of a bone discontinuity, such as a fracture 21 or a cut within onebone (intra-bone fixation), or a joint between different bones(inter-bone fixation), among others. Plate members 24, 26 may beconnected by a mechanical joint 38. Joint 38 may be configured to permitplate members 24, 26 to pivot and/or move translationally so that theangular disposition (the alignment) and/or spacing, respectively, of theplate members can be adjusted. In the present illustration, joint 38permits both pivotal and translational movement of the plate members.

FIG. 1B shows an improved alignment of bone portions 32, 34 afterpivotal movement, indicated as step 40, of first plate member 24 andsecond plate member 26 relative to one another. The pivotal movement maybe about one axis, such as about an axis generally normal to the platemembers, or about two or more axes. For example, joint 38 may beconfigured so that the first and second plate members can bend and twistrelative to one another about three orthogonal axes.

FIG. 1C shows the result of optional translational movement, indicatedas step 42, of first plate member 24 and second plate member 26 towardone another. The translational movement may adjust the spacing of thebone portions, for example, compressing (or distracting) the boneportions toward (or away from) one another, or shifting a plate memberlaterally. After pivotal and/or translational movement of the platemembers, further relative movement of the plate members at joint 38 maybe restricted by adjustment of a detent mechanism 44, such as a screw,to place joint 38 in a fixed configuration.

Pivotal and/or translational movement of the plate members relative toone another may be effected via any suitable mechanism, includingmanipulation of the bones and/or body portions connected to the bones,and/or manipulation of the bone plates and/or handles or other devicesassociated with the bone plates. Such manipulation may be performed byhand and/or using a tool. For example, in FIG. 1, pivotal and/ortranslational movement may be directed by a handle (or handles) 46connected to one or more of the plate members (see FIGS. 1A and 1B). Thehandle may be grasped by hand or with a tool to apply a directionalforce, such as a torque, to one of the plate members. To increase torqueby increasing the lever arm, the handle(s) may be positioned relativelyfar from the joint(s), and/or be relatively long. The handle may beremoved after plate adjustment has been completed, as shown in FIG. 1C.In some embodiments, removal of the handle may include disconnecting thehandle, for example, by rotation of the handle to disengage threads ofthe handle from a threaded opening of the bone plate.

Further aspects of the invention are described in the followingsections, including (I) overview of bone plates, (II) plate members,(III) joints of bone plates, (IV) reference marks, and (V) examples.

I. OVERVIEW OF BONE PLATES

Bone plates as described herein generally comprise any relativelylow-profile (or plate-like) fixation device configured to stabilize atleast one bone by attachment to the bone. The fixation device may beconfigured to span a bone discontinuity (such as a fracture, a cut, abone joint, etc.) so that the fixation device fixes the relativepositions of bone portions disposed on opposing sides of the bonediscontinuity. The fixation device generally is configured to bedisposed in contact with an outer surface of the bone and thus may bepositioned at least substantially exterior to the bone. The bone platemay be left in place permanently or removed after the associated bonehas partially or completely healed.

The bone plates may be of a sturdy yet malleable construction.Generally, the bone plates should be stiffer and stronger than thesection of bone spanned by the plates, yet flexible (e.g., springy)enough not to strain the bone significantly. Suitable materials may bebiocompatible materials (such as titanium or titanium alloys, cobaltchromium, stainless steel, plastic, ceramic, etc.) and/or bioabsorbablematerials (such as polygalactic acid (PGA), polylactic acid (PLA),copolymers thereof, etc.), among others.

The bone plates may be configured to reduce irritation to the bone andsurrounding tissue. For example, the bone plates may be formed of abiocompatible material, as described above. In addition, the bone platesmay have a low and/or feathered profile to reduce their protrusion intoadjacent tissue and rounded, burr-free surfaces to reduce the effects ofsuch protrusion.

The bone plates may have at least one, and generally two or more,distinct anchor (or bone-attachment) portions, configured to be securedto a bone. Each anchor portion may be structured for a specific portionof a bone, generally to fit against a surface region of bone adjacent abone discontinuity. For example, the bone plates may include a proximalanchor portion for attachment to a more proximal region of a bone, and adistal anchor portion for attachment to a more distal region of the samebone. In some embodiments, the bone plates may include a support (orbuttress) portion connected to an anchor portion. The support portionmay lack connective features that permit a direct connection of thesupport portion to the bone with one or more fasteners. Such a supportportion may limit movement of a bone fragment using contact between thesupport portion and the fragment, and may include projections or prongsto engage the fragment more effectively.

The bone plates described herein may be sized and shaped to conform toparticular portions of a bone (or bones). The plates may be generallyelongate, with a length L, a width W, and a thickness T. Here, lengthL≧width W≧thickness T. In use, the long axis of the bone plates may bealigned with the long axis of the corresponding bone or may extendobliquely or even transversely relative to the bone's long axis. Thelength and/or width of the bone plates may be varied according to theintended use, for example, to match the plates with a preselected regionof bone(s) and/or a particular injury to the bone. For example, theplates may be generally linear for use on the shaft of a long bone ormay have a nonlinear shape, such as for use near an end of a bone. Insome embodiments, the plates may be generally T-shaped, including anaxial portion, for attachment to a shaft portion of a bone, and atransverse portion connected to the axial portion, to provide a widerplatform for attachment near an end of the bone. In some embodiments,the bone plates may be configured for use on both sides of the body,such as when the bone plates are bilaterally symmetrical. In someembodiments, the bone plates may be asymmetrical and configured for useon either the left or the right side of the body.

The bone plates described herein may be configured for use on anysuitable bone of the human body and/or of another vertebrate species.Exemplary bones may include bones of the arms (radius, ulna, humerus),legs (femur, tibia, fibula, patella), hands, feet, the vertebrae,scapulas, pelvic bones, cranial bones, and/or the ribs and clavicles,among others. Particular examples where pivotable bone plates may besuitable include the distal radius (such as the volar surface of thedistal radius) and the distal tibia.

The bone plates may include inner (bone-facing) and outer(bone-opposing) surfaces. One or both of these surfaces may be contouredgenerally to follow a surface of a target bone (or bones) for which thebone plates are intended, so that the bone plates maintain a low profileand fit onto the bone(s). For example, the inner surface of a plate maybe generally complementary in contour to the bone surface. The outersurface may correspond in contour to the bone surface and may becomplementary to the inner surface of the plate.

The thickness of the bone plates is defined by the distance between theinner and outer surfaces of the plates. The thickness of the plates mayvary between plates and/or within the plates, according to the intendeduse. For example, thinner plates may be configured for use on a smallerbone and/or on a bone or bone region where soft tissue irritation is agreater concern. Thickness may be varied within the plates. For example,the plates may become thinner as they extend over protrusions (such asprocesses, condyles, tuberosities, and/or the like), reducing theirprofile and/or rigidity, among others. The thickness of the plates alsomay be varied to facilitate use, for example, to make the plates thinnerwhere they typically need to be deformed by bending and/or twisting theplates. In this way, the plates may be thicker and thus stronger inregions where they typically do not need to be contoured, such as alongthe shaft of the bone.

The bone plates generally include a plurality of openings. The openingsmay be adapted to receive fasteners for securing the plates to bone.Alternatively, or in addition, the openings may be adapted to alter thelocal rigidity of the plates, to permit the plates to be manipulatedwith a tool (such as an attachable handle), and/or to facilitate bloodflow to the fracture or surgical site to promote healing, among others.

The openings may have any suitable positions, sizes, and/or densitieswithin each portion of a bone plate. The openings may be arrayedgenerally in a line along a portion of the plate, for example, centeredacross the width of the plate. Alternatively, the openings may bearranged nonlinearly, for example, disposed in a staggered arrangement.In some embodiments, the openings may be configured so that a set ofbone screws can be directed along nonparallel paths, for example, toincrease the purchase of the set of bone screws on bone. Further aspectsof openings configured to direct bone screws along nonparallel paths areincluded in the following patent application, which is incorporatedherein by reference: U.S. Provisional Patent Application Ser. No.60/512,111, filed Oct. 17, 2003.

The openings may have any suitable shape and structure. Exemplary shapesmay include circular, elliptical, rectangular, elongate, etc. Theopenings may include counterbores configured, for example, to receive ahead of a bone screw. The openings may be threaded or nonthreaded, andeach bone plate may include one or more threaded and/or nonthreadedopenings. In some embodiments, the plates may include one or a pluralityof elongate openings (slots) extending axially and/or transversely alongeach bone plate. The slots may include counterbores that providecompression when bone screws are advanced against the counterbores.Alternatively, or in addition, the slots may be used to adjust theposition of bone plates and/or plate portions relative to bone beforethe plates are fully secured to the bone. Further aspects of openings orslots that may be suitable for pivotable bone plates are described inmore detail in the following patent applications, which are incorporatedherein by reference in their entirety for all purposes: PCT PatentApplication Ser. No. PCT/US02/18623, filed Jun. 10, 2002; and U.S.patent application Ser. No. 10/717,015, filed Nov. 19, 2003.

The fasteners generally comprise any mechanism for affixing a bone plateto a bone, including screws, pins, and wires, among others. A preferredfastener is a bone screw, including unicortical, bicortical, and/orcancellous bone screws. Unicortical and bicortical bone screws typicallyhave relatively small threads for use in hard bone, such as typicallyfound in the shaft portion of a bone, whereas cancellous bone screwstypically have relatively larger threads for use in soft bone, such astypically found near the ends (periarticular regions) of a long bone.Unicortical bone screws penetrate the bone cortex once, adjacent thebone plate. Bicortical bone screws penetrate the bone cortex twice,adjacent the bone plate and opposite the bone plate. Generally,unicortical screws provide less support than bicortical screws, becausethey penetrate less cortex. The size and shape of the fasteners may beselected based on the size, shape, and disposition of the openings, orvice versa. For example, unicortical bone screws may be suitable withparticular arrangements of openings.

II. PLATE MEMBERS

The anchor and/or buttress portions of a bone plate may be defined byseparate components of the bone plate, termed plate members. Each platemember may define a different anchor and/or buttress portion of the boneplate. The pivotable bone plates described herein may include two ormore plate members. In some embodiments, the bone plates may include atleast three plate members, with each adjacent pair of plate membersconnected by a mechanical joint.

Plate members may have any suitable size and shape. Generally platemembers may be sized and shaped according to a target bone portion forwhich each plate member is intended. Accordingly, the plate members of abone plate may be configured to correspond to the anchor and/or buttressportions of a bone plate lacking a mechanical joint (that is, a unitarybone plate). In some embodiments, one or more of the plate members maybe generally linear and/or generally T-shaped.

The plate members may be configured to be secured to (and/or engage)different portions of one bone or two or more bones. Accordingly, eachplate member may include one or more connective features. A connectivefeature may be any structure of the plate member that permits couplingof the plate member to a fastener or to bone. Exemplary connectivefeatures may include a threaded opening to be engaged by a threadedfastener, a nonthreaded opening to be engaged by any screw and/or awire, a hook, a pin, a prong, and/or the like. Each plate member mayhave no openings (for example, a plate member configured to buttressbone), one opening, or two or more openings. With two or more openings,the plate member may have all threaded openings, all nonthreadedopenings, and/or a combination of threaded and nonthreaded openings,among others. In some embodiments, a plate member may have an openingconfigured to be engaged by a tool, such as a threaded or nonthreadedhandle, to facilitate manipulation of the plate member, particularlyafter the plate member and/or its corresponding bone plate have beenattached to bone.

III. JOINTS OF BONE PLATES

The bone plates described herein may include one or more joints. Eachjoint may be any connection between plate members that permits the platemembers to move relative to one another. The joint(s) may be disposed topermit plate members of a bone plate to move rotationally (bend and/ortwist) and/or translationally relative to one another, so that theangular disposition and/or spacing of the plate members may be adjusted.Each joint may have (1) an adjustable configuration in which the platemembers can be moved independently, and (2) a fixed configuration inwhich the angular disposition and/or spacing of the plate members arefixed.

A joint may be formed at a bridge region between plate members. Thebridge region may be defined by direct contact between plate membersand/or may include one or more additional components, such as a bridgemember, that spans a gap between the plate members. In some embodiments,the joint may include generally complementary surfaces of plate membersthat contact one another to guide sliding movement (translational and/orpivotal) of the surfaces (and thus the plate members) relative to oneanother. The generally complementary surfaces may have any suitableshape(s), including semi-spherical (or spherical), planar, curved (suchas semi-cylindrical), etc.

The joint may be pivotable. A pivotable joint may be pivotable about asingle axis or a plurality of two or more nonparallel (or parallel)axes. The axis may be the long axis of the plate (or of a plate member)to achieve twisting of the plate. Alternatively, or in addition, theaxis may be a normal or “vertical” axis disposed generally orthogonal toa plane defined by the plate (or one of the plate members). Furthermore,the axis or axes may be one or more transverse or “horizontal” axesextending obliquely and/or orthogonally to the long axis of the plate orplate member. Pivotal movement about the normal and/or transverse axesprovides bending of the plate.

Any suitable types of pivotable joints may be included in the boneplates. In some embodiments, the joint may permit pivotal movement aboutthree orthogonal axes. An exemplary pivotable joint that allows platemembers to be pivoted about three orthogonal axes is a ball joint(ball-in-socket). The ball joint includes at least one joint surfaceshaped generally as a complete sphere or as a portion of a sphere(semi-spherical). In some embodiments, a ball joint with a portion of asphere may be preferred over a full sphere joint to minimize the profileof the joint. A ball joint may permit plate members to bend and twistrelative to one another. Alternatively, the joint may be a hinge joint(a pin in a hole) that permits pivotal movement about only one axis. Insome embodiments, the joint may be two or more joints that permitpivotal movement about spaced axes, such as spaced orthogonal axes (seeExample 4 below). In some embodiments, the joint (or joints) may permitchanges of angular disposition coupled with translational movement (seeExample 5 below).

Any pivotable joint may be locked with a detent mechanism, to fix theangular disposition of the plate members. An exemplary detent mechanismincludes a fastener, such as a screw or bolt. The fastener may bereceived threadedly to engage, compress, and/or expand a plate member(s)and/or an associated component, such as bridge member, to provide, forexample, frictional engagement and thus restrict movement. In someembodiments, the detent mechanism may compress plate members together.In some embodiments, the detent mechanism may include a conical screwthat expands a joint component, as the conical screw is advanced.

Any suitable structures may be included at the joint to guide and/orlimit movement of plate members. Such guiding/limiting structures mayinclude ridges and/or other projections that slide in grooves, a pin orfastener guided by a slot, and/or teeth/serrations received by acorresponding set of depressions or complementary teeth/serrations,among others. The guiding/limiting structures may allow continuousadjustment (for example, a ridge sliding in a groove or a ball rotatingin a socket), or discrete adjustment positions (for example, serrationsreceived by depressions). The guiding/limiting structures may restrictseparation of the plate members (for example, a dovetail ridge receivedin a corresponding dovetail groove).

Sliding may be permitted by the guiding/limiting structures along one orplural axes. For example, sliding may be permitted along the long axisof the plate, to adjust the length of the plate. Alternatively, or inaddition, sliding may be permitted transversely, for example, to offsetplate members or to adjust the transverse position of a transverselyextending plate member, such as in a T-shaped bone plate.

A slidable junction may be locked in position by any suitable detentmechanism. The detent mechanism may provide a continuous range of lockedpositions or only discrete locked positions. For example, the detentmechanism may be a fastener, such as a screw (or screws). The screw maybe positionable within a slot defined by one plate member to allow acontinuous range of adjustments. Alternatively, the screw may bereceived in one of a limited set of aligned apertures defined by theplate members to provide discrete locked positions. In otherembodiments, the detent mechanism for translational (and/or pivotal)movement may be a tab or button that is bent, depressed, or otherwisemoved into a retaining position.

Further aspects of adjustable bone plates having pivotable and/orsliding joints (and/or deformable portions) are described in theExamples below and in the following patent application, which isincorporated herein by reference in its entirety for all purposes: U.S.patent application Ser. No. 10/717,402, filed Nov. 19, 2003.

IV. REFERENCE MARKS

The bone plates may include reference marks. The reference marks may bedisposed adjacent a pivotable joint, a linearly slidable joint, and/or aslot, among others. The reference marks may indicate an angulardisposition and/or a linear disposition of one portion of a bone platerelative to another. Alternatively, the reference marks may indicate aposition of a bone screw within a slot. The reference marks may be anyvisible indicia on the bone plate. These indicia may be formed onto orinto the plate during initial production, for example, by casting theplate using a mold configured to form the indicia (e.g., ridges orgrooves in the mold to form grooves or ridges in the plate,respectively). Alternatively, or in addition, the indicia may be addedto the plate after production, for example, by etching or cutting theminto existing components of the plate, and/or adding them as additionalcomponents of the plate. In some cases, indicia may alternatively oradditionally be included on a guide or template that is placed inapposition to the plate before or during installation, and then removedbefore the end of installation. Exemplary reference marks may includedots, dashes, symbols, numbers, letters, words, shapes, and/or colors,among others.

In some embodiments, a first plate member of a bone plate may have anarcuate (or linear) array of reference marks, and a second plate memberof the bone plate may have a single reference mark or landmark. Thearcuate array may include numbers or letters corresponding to differentangular (or translational) positions. The numbers may include positiveand negative numbers to indicate opposite directions of pivotalmovement. The array of reference marks may be compared against thelandmark during relative rotation (or translational movement) of one ofthe plate members relative to the other, to measure an angular (ortranslational) adjustment. Such an angular (or translational) adjustmentmay be predetermined, for example, by analysis of an x-ray, the boneitself, or tissue supported by the bone. Toward this end, correspondingor complementary reference marks may be included on instruments or toolsused to select and/or install the bone plate, such as x-ray templates,measuring guides, and so on. Alternatively, or in addition, standard ortypically used settings for the reference marks may be noted on theplate, for example, by identifying these marks using additional indicia(such as a star “*”). The adjustment may be assigned a numerical value,such as an angle or a distance. The reference marks may be configured toindicate a range of angle or distances, so that these marks indicatewhen the numerical value of adjustment has been reached during movementof the plate members. Pivotable bone plates with reference marks may besuitable for fixing osteotomies or fractures, or fixing different bonesacross bone joints, among others.

Further aspects of pivotable bone plates with reference marks aredescribed in Example 7 below and in the following patent application,which is incorporated by reference herein in its entirety for allpurposes: U.S. patent application Ser. No. 10/717,399, filed Nov. 19,2003.

V. EXAMPLES

The following examples describe selected aspects and embodiments of theinvention, including pivotable bone plates and exemplary uses of thepivotable bone plates to fix bones. These examples are included forillustration and are not intended to limit or define the entire scope ofthe invention.

Example 1 Exemplary Fracture for Fixation with Pivotable Bone Plates

This example describes an exemplary fracture that may be fixed withpivotable bone plates of the present teachings; see FIG. 2.

FIG. 2 shows an upper right extremity 60 exhibiting a Colles' fracture62, which is a very common fracture of the distal radius 64 typicallycaused by using an outstretched hand to break a fall. The position ofthe fracture is indicated relative to the skin of the distal forearm 66and hand 68, which is shown in phantom outline. In Colles' fracture 62,a smaller, distal bone fragment 70 may be displaced dorsally from alarger, proximal bone segment 72 of the radius bone. Colles' fracture 62may be reduced and fixed with the pivotable bone plates described hereinby placement of a bone plate on the volar (anterior or lower) side 74 ofthe radius. This placement may reduce or avoid tendon irritation thatmay occur with flexion when the bone plate is attached to the dorsal(posterior or upper) side 76 of the radius. Alternatively, the boneplates described herein may be used on the dorsal surface of the distalradius or on any other suitable bone(s) or bone surface(s).

Example 2 Bone Plate with Joint for Pivotal Movement about Three Axes

This example describes a bone plate, for use on a fractured distalradius, in which portions of the bone plate can bend and twist relativeto each other; see FIGS. 3-6.

FIGS. 3 and 4 show a lateral-medial sectional view and a volar view,respectively, of fractured radius 64 with a pivotable bone plate 80affixed to radius adjacent volar surface 74. Pivotable bone plate 80 mayinclude a proximal plate member 82 and a distal plate member 84connected by a pivotable joint 86.

Proximal plate member 82 may have its long axis disposed generallyparallel to the long axis of the radius. Plate member 82 may begenerally linear. Plate member 82 may be secured to proximal segment 72of the radius with a plurality of bone screws 88. Bone screws 88 may bebicortical bone screws or may be unicortical bone screws, as shown here.Bone screws 88 may be directed along parallel or nonparallel pathsdefined by openings 90-94 of the proximal plate member.

The paths the bone screws travel may be defined by a fit betweenfasteners (such as bone screws or pins) and the openings. The fit may bea close fit that at least substantially defines the angle at which afastener travels through the bone plate and into bone, for placement ofthe fastener at a predefined angle. Alternatively, the fit may be a lessrestrictive fit that permits placement of the fastener at a selectedangle within a range of angles. The type of fit for each fastener may bedetermined by a surgeon during installation of the bone plate byselection of each fastener.

A close fit may be defined by threaded or nonthreaded engagement of thefastener with the wall of the opening. The close fit may be defined bythreaded engagement of a threaded fastener with a correspondinglythreaded opening. The threaded engagement may predefine the angle andlock the axial position of the fastener relative to the screw's longaxis. Alternatively, or in addition, the close fit may be defined by aclose correspondence of the diameter of the fastener's shank and thediameter of the opening, particularly a cylindrical portion of theopening. The diameter of the fastener may be defined by a threaded ornonthreaded segment of the shank of the fastener (generally adjacent thehead of the fastener). The diameter of the opening may be defined by anonthreaded or threaded opening. Accordingly, a close fit at apredefined angle may be achieved by a nonthreaded or threaded shaftsegment engaged by either of a threaded or nonthreaded opening.

A less restrictive fit may be defined by the size and/or shape of theopening in relation to the size and/or shape of the fastener. Forexample, the opening may have a diameter sufficiently greater than thediameter of the fastener to permit the fastener to achieve differentangular dispositions within the opening. Alternatively, or in addition,the opening may have angled or curved walls to permit the fastener topivot to different angular dispositions.

One or more of the openings, such as openings 92, 94, may be elongateopenings or slots. The slots may be disposed axially and/or transverselyon the plate member(s). The slots may have reference marks 98 disposedadjacent the slots (see FIG. 5). The reference marks may be configuredto measure movement of the bone plate in the direction in which eachslot extends. In some embodiments, the slots may be configured to permitaxial and angular adjustment of the proximal plate member 82 with bonescrews placed into bone from one or both of slots 92, 94, and beforeadditional bone screws are placed through openings 90 and into bone.Further aspects of slots for positioning bone plates are included in thefollowing patent application, which is incorporated herein by reference:U.S. patent application Ser. No. 10/717,015, filed Nov. 19, 2003.

Distal plate member 84 may have its long axis disposed transverse of thelong axis of the radius. Plate member 84 may be generally T-shaped orfan-shaped. Plate member 84 may be secured to distal fragment 70 of theradius with a plurality of unicortical or bicortical bone screws 102placed through openings 104 of the distal plate member and into bone.Openings 104 may be threaded, nonthreaded, or a mixture thereof. Thebone screws may be selected for threaded or nonthreaded engagement withopenings 104. Furthermore, each bone screw may be selected so that theangle of placement of a particular bone screw (or other fastener) ispredefined by opening 104 or selectable within a range of angles, asdescribed above for openings 90-94.

Pivotable joint 86 may be configured to permit bending and twisting ofdistal plate member 84 relative to proximal plate member 82, before,during, and/or after the plate members are secured to the distal radius.FIG. 5 indicates bending movements 106, 108 about two axes and twistingmovement 110 for the distal plate member.

FIGS. 3 and 4 show the position of bone plate 80 before final pivotaladjustment of the plate members and thus before final reduction offracture 62. Pivotal adjustment may be accomplished, for example, by (1)placing joint 86 in an adjustable configuration by loosening lock screw112, (2) rotating distal plate member 84 about one or more axes (such asclockwise in both FIGS. 3 and 4), by corresponding movement of connectedhandle 114, and (3) placing joint 86 in a fixed configuration bytightening lock screw 112 to fix the relative positions of the platemembers and their attached bone portions.

FIGS. 5 and 6 shows additional aspects of pivotable bone plate,particularly aspects of pivotable joint 86. Joint 86 may include upperand lower semi-spherical surfaces 122, 124 included in the platemembers. Semi-spherical surfaces 122, 124 may be convex and concave,respectively, and may have a similar radius of curvature. Accordingly,upper surface 122 may slide along lower surface 124 to achieve pivotalmovement about three orthogonal axes. The upper and lower surfaces maybe held in apposition by a semi-spherical retainer 126, generally in theform of a washer, and lock screw 112. The semi-spherical retainer may beconfigured to be received in a semi-spherical cavity 128 defined by thedistal plate member. The retainer and semi-spherical cavity may havesimilar radiuses of curvature.

Pivotable joint 86 may include a detent mechanism 129 to restrictpivotal movement, In particular, the detent mechanism may include lockscrew 112 received in openings 130, 132 of the retainer and distal platemember, respectively, and rotated into threaded engagement with athreaded bore 134 of the proximal plate member. The lock screw thus maybe advanced or retracted to define the amount of frictional engagementbetween plate member surfaces 122, 124, to determine whether thesesurfaces are movable or fixed relative to one another. In someembodiments, the proximal plate member may include lower surface 124 andthe distal plate member may include upper surface 126. Alternatively, orin addition, other aspects of the pivotable joint may be inverted fromthe configuration shown here, so that retainer 126 may be threaded andconfigured to serve as a nut disposed adjacent the bone. In this case,lock screw 112 may be placed through openings in each of the platemembers from the outer surfaces of the plate members and into threadedengagement with the retainer.

Bone plate 80 may include inner surfaces 140, 142 and outer surfaces144, 146 (see FIG. 6) on the plate members. Inner surfaces 140, 142 maybe configured to be generally coplanar when the bone plate is in aneutral adjustment position, as shown here, or may not be coplanar.Openings, such as opening 90, may be defined between the inner and outersurfaces. The openings may include counterbores 148 and bores 150. Bores150 may be cylindrical or may be flared toward the inner surface, amongothers.

Example 3 Bone Plate with Joints for Pivotal and Translational Movement

This example describes a bone plate, for use on a fractured distalradius, in which portions of the bone plate can bend, twist, and slidetranslationally relative to each other; see FIGS. 7 and 8.

Bone plate 170 may include a proximal plate member 172, a distal platemember 84, and a bridge member 174 connecting the two plate members. Thebone plate may include two joints that permit pivotal and translationalmovement of the plate members, pivotable joint 86 and translationaljoint 175. Pivotable joint 86 may be configured as described above forExample 2 and will not be addressed further here.

Translational joint 175 may be defined by a telescoping relation ofbridge member 174 with proximal plate member 172. In particular, bridgemember 174 may include opposing, elongate ridges or guides 176configured to be received in complementary elongate recesses or tracks178 defined by the proximal plate member.

The axial position of bridge member 174 may be fixed by a detentmechanism 180. The detent mechanism may include a retainer 182 (such asa washer) and a fastener 184 (such as a screw or bolt). The fastener maybe placed through the retainer and into threaded engagement with athreaded bore 186 of bridge member 174. Advancement of the fastener intothe threaded bore may push retainer 182 into engagement with retentionsurfaces 188 of the proximal plate member 172, thereby restrictingtranslation movement. The retainer may be loosened to permit furthersliding at joint 175.

Before and/or after fixing joint 175, bone screws 190 may be placedthrough openings 192 of proximal plate member 172 and into bone. Bridgemember 174 may include elongate passages 194 to permit the bone screwsto be received over a continuous range of axial positions of the bridgemember. The passages may be configured to permit the heads of bonescrews to advance through the passages, or the heads of the bone screwsmay be engaged by the bridge member.

Example 4 Bone Plate with Spaced Pivotable Joints

This example describes a bone plate with a plurality of spaced jointsconfigured for pivotal movement about orthogonal axes; see FIG. 9.

Bone plate 210 may include two pivotable joints 212, 214 connectingproximal plate member 216 and distal plate member 218 using bridgemember 220. Pivotable joint 212 may permit pivotal movement, shown at222 about a normal axis 224. Joint 212 may be defined by apposition ofdistal plate member 218 with bridge member 220 at contact surfaces 226,228 of these members. Contact surfaces 226, 228 may be generally planar.The contact surfaces may include serrations or other complementarystructures to restrict pivotal movement when a detent mechanism 230 isactuated.

Detent mechanism 230 may be provided by a connector 232, such as ascrew, that passes through an opening 234 in distal plate member 218 andinto threaded engagement with a threaded bore 236 of bridge member 220.Advancement of connector 232 may compress the distal plate member andthe bridge member together to restrict pivotal movement. Surfacefeatures of contact surfaces 226, 228 may facilitate restrictingmovement when the detent mechanism is actuated.

Hinge joint 214 may permit pivotal movement, shown at 240, about atransverse axis 242. The hinge joint may be formed between bridge member220 and proximal plate member 216. Detent mechanism 244 of the hingejoint may include a lock screw 246 that acts axially on the hinge joint,to compress the hinge joint parallel to axis 242. In some embodiments,the detent mechanism may act radially on the hinge joint, among others.

Example 5 Bone Plate with Integrated Joint for Sliding and Pivoting

This example describes a bone plate, for fixing a fractured radius, inwhich the plate an integrated joint for sliding and pivoting; see FIG.10.

Bone plate 270 may include a proximal plate member 272 and a distalplate member 274 connected at joint 276. Joint 276 may permit axialmovement, shown at 278, and pivotal movement, shown at 280, about axis282. The plate members may include contact surfaces 284, 286 that slidetranslationally and pivot relative to one another. The plate members maybe connected by connectors 288, 290 (such as screws), that extendthrough elongate openings 292, 294 and into a threaded hole 296 and athreaded slot 29, respectively. The plate members may be adjustedpositionally by pivotal and translational movement of the plate members,and then fixed in position by advancing connectors 288, 290 until theirheads apply a compressive force to the counterbore surfaces 302, 304 ofdistal plate member 274.

Example 6 Bone Plate with Coupled Translational and Pivotal Movement

This example describes a bone plate, for fixing a fractured radius, inwhich the bone plate couples translational and pivotal movement; seeFIGS. 11-14.

FIG. 11 shows a bone plate 320 having a proximal plate member 322 and adistal plate member 324 connected by two joints 326, 328. First joint326 permits pivotal movement, shown at 330, about normal axis 332 andthus is similar to joint 212 of Example 4. Second joint 328 may bedisposed under or over the first joint, among others, and may beconfigured to permit the plate members to slide translationally.However, the path along which the plate members slide may be arcuate, asdescribed further below, so that the second joint permits coupledtranslational and circular movement.

FIG. 12 shows an axial sectional view of selected portions of bone plate320. The plate members 322, 324 may be connected via a bridge member 340that contacts the plate members on opposing surfaces 342, 344 of thebridge member. Upper surface 342 may provide a contact surface forpivotal movement of proximal plate member 322 at first joint 326. Lowersurface 344 may provide a contact surface that defines a curved path,indicated at 346, along which distal plate member 324 slides. The curvedpath may be along a circular path, as indicated by an alternate positionof proximal plate member 322 achieved by sliding along path 346, shownin phantom outline at 348.

FIGS. 13 and 14 show a transverse sectional view and an exploded view,respectively, of bone plate 320. Joints 326, 328 may include a detentmechanism 350 having a connector 352. The connector may be a screw,among others, that extends through openings in proximal plate member 322and bridge member 340. The screw may be received by a threaded nut 354retained in a slot 356 defined by distal plate member 324. Slot 356 maybe narrowed adjacent the bridge member to define walls 358 that engageshelves 360 of the nut, to retain the nut in slot 356.

Example 7 Bone Plate with Reference Marks

This example describes a bone plate with reference marks configured tomeasure angular and/or translational adjustment of the plate; see FIGS.15 and 16.

FIG. 15 shows a bone plate 390 in an exploded view. Bone plate 390 maybe configured, for example, to fix the position of cut bone portionsafter an osteotomy. Bone plate 390 may include an axial (or proximal)plate member 392 and a transverse (or distal) plate member 394 connectedby a pivotable joint 396. Pivotable joint 396 may enable transverseplate member 394 to pivot, shown at 397, about one axis, such as normalaxis 398. Alternatively, the pivotable joint may be configured to permitpivotal movement about two or more axes, as described elsewhere in thepresent teachings. Pivotable joint 396 may be adjustable and thenfixable with a lock screw 402 or other detent mechanism.

Bone plate 390 may include an angular indicator mechanism 404 includingangular reference marks 406 and a landmark 408. Angular reference marks406 and landmark 408 may be disposed on different plate members 392,394, respectively, or vice versa.

The bone plate also may include slot 410 and a linear indicatormechanism 412 that provides an axial measure of plate adjustment. Slot410 may extend in alignment with the long axis of axial plate member392. Slot 410 may receive a bone screw that guides linear sliding of thebone plate in relation to the bone screw (and thus underlying bone).Linear sliding may provide axial adjustment of the bone plate before thebone screw is fully tightened and/or before other bone screws are placedinto bone from additional openings 414 of the bone plate. Linear slidingmay be performed before and/or after bone screws have been placed intobone from openings 416 of the opposite (e.g., transverse) platemember(s). Positions within linear slot 410 may be indicated byreference marks 418 arrayed parallel to the slot adjacent an edge of theslot. Linear reference marks may have any suitable spacing andorientation, and may have any suitable form, including alphanumericcharacters (such as numbers or letters), symbols, and/or other indiciathat identify and/or distinguish individual marks.

FIG. 16 shows a plan view of angular indicator mechanism 404 of boneplate 390. Mechanism 404 may include angular reference marks 406 arrayedin an arcuate arrangement. The reference marks may include line segmentsthat extend radially from pivot axis 398 and/or may include dots and/ordashes, among others. Adjacent pairs of reference marks 406 may defineany suitable angle with pivot axis 398 of pivotable joint 396. Forexample, adjacent reference marks may define an angle of 1, 2, 5, or 10degrees, among others. In some embodiments, reference marks 406 mayinclude major and minor marks that are visibly distinguishable, such aslonger marks, shown at 420, spaced here by thirty degrees, and flankingshorter marks, shown at 422, spaced here by ten degrees, among others.Indicator mechanism 404 also or alternatively may include alphanumericcharacters, such as numbers 424, which identify particular referencesmarks and/or serve as such marks. In some cases, standard (e.g.,preferred and/or typically used) settings for the reference marks may benoted on the plate, for example, by using an alternative font, symbol,or size, and/or by identifying these marks using additional “standardsetting” marks 426 (such as a star “*”).

Landmark 408 may be configured to provide a site against which thereference marks 406 are compared, for example, to identify one of thereference marks that is most closely aligned with the landmark. Forexample, in the present illustration landmark 408 is aligned with thereference mark labeled as “−30” to indicate a 30 degree rotation of thetransverse plate member from a neutral position of zero degrees. Angularreference mechanism 404 may be used to adjust the angular position oftransverse plate member 392 by a predetermined angle. The angle may bepredetermined by any suitable analysis, such as examining an x-ray ofthe bone to which the plate is attached, measuring the angle of bone orlimb misalignment with an external measuring device, etc.

The uses for reference marks in bone plates with reference marks mayextend to pre- and/or postoperative analysis. For example, beforeinstalling a bone plate, a surgeon could “dial in” or otherwise presetapproximate settings for the bone plate. The preset value could bedetermined from preoperative analysis (e.g., using x-ray templatesand/or other measurement tools having corresponding or complementaryreference marks), comparison with a corresponding uninjured feature onan opposite side of a patient's body (e.g., using measurements of anuninjured left radius to determine suitable preset values for an injuredright radius), comparison with statistical data collected from a varietyof patients (e.g., in the form of a lookup table), and so on.Alternatively, or in addition, after installing a bone plate, a surgeoncould record the final settings, for possible postoperative use. In somecases, reference marks may be readable in situ using x-rays, magneticresonance, and/or similar techniques, to allow noninvasive monitoring ofthe continued proper placement and adjustment of the platepostoperatively. Suitable reference marks for such use include changesor alterations in the thickness, profile, and/or composition of theplate, among others.

Example 8 Pivotable Bone Plate

This example describes another pivotable bone plate, for use on afractured distal radius, in which portions of the bone plate can bendand twist relative to each other; see FIGS. 17-19. Some aspects of thisbone plate are shared with the bone plate described above in Example 2and are described in more detail therein.

FIG. 17 shows a bone plate 450 configured for use on a volar surface ofthe distal radius. Bone plate 450 may be asymmetrical and configured foruse on only one side of the body, on the left radius in the presentillustration. Bone plate 450 may include a proximal anchor portion 452,a distal anchor portion 454, and a pivotable joint 456 connecting theproximal and distal anchor portions.

Proximal anchor portion 452 may be an axial portion configured to begenerally aligned with the long axis of the radius. Proximal anchorportion 452 may define a plurality of openings, 458-464, for receivingfasteners, such as bone screws. Proximal opening 464 may be a slotdisposed in general alignment with the long axis of proximal anchorportion 452. Each of the openings may be threaded or nonthreaded and mayinclude or lack a counterbore. In some embodiments, one or more of theopenings, such as opening 458, may be configured as a transverse slot.At least a subset of the openings may be disposed in a staggeredarrangement, such as on opposing sides of a central axis 466 of theplate, to direct bone screws along staggered, nonparallel paths, asdescribed in U.S. Provisional Patent Application Ser. No. 60/512,111,filed Oct. 17, 2003. Accordingly, openings of this subset may definedifferent paths of travel for bone screws based on differentorientations of the walls of the openings and/or threads thereof. Theperimeter of proximal anchor portion 452 may generally follow thedisposition of the openings, shown at 468, to create a wavy or wigglyappearance to the proximal anchor portion when viewed from a positionnormal to a plane defined by the plate. Proximal anchor portion 452 alsomay include one or more smaller openings 470, configured, for example,to receive a fastener of smaller diameter, such as a wire.

Distal anchor portion 454 may be configured to be secured to the wideneddistal region of the radius. Accordingly, distal anchor portion 454 maybe wider than proximal anchor portion 452 and may flare distally, toproduce a fan-like shape, so that the plate overall is generallyT-shaped. Distal anchor portion 454 may define a plurality of openings472, 474 arrayed in a direction generally transverse to central axis 466of the proximal anchor portion 452, when the plate is adjusted to aneutral position as shown here. Openings 472, 474 may be arrayed in oneor more linear or arcuate rows, among others.

The distal openings may be threaded, shown at 472, or nonthreaded, shownat 474, or a combination thereof, as in the present illustration (seeFIG. 18 also). Each opening may be configured to receive a bone screw orother fastener (such as a pin) at a fixed angle or at a selected anglewith a range of angles. The choice between a fixed or variable angle maybe defined by how closely the screw or other fastener fits into theopening, and/or whether threaded engagement is used to fix the angle ofthe screw/fastener, as described above in more detail in Example 2.

Distal anchor portion 454 may include one or more additional openings476 disposed distally of openings 472, 474. Distal opening 476 may beused, for example, to receive a fastener placed into the styloid processof the distal radius, particularly when the styloid process has beenfractured or cut.

Distal anchor portion 454 may be contoured to fit on the volar surfaceof the distal radius. Accordingly, the distal anchor portion 454 mayhave an inner surface 478 that is transversely convex and an outersurface 480 that is transversely concave, particularly in a proximalsection 482 of distal anchor portion 454. A distal section 484 of distalanchor portion 454 may be configured to be disposed distally of avolar-distal rim of the radius. Accordingly, distal anchor portion 454may include a transverse contour 486, such as a slight depression, atthe junction between proximal and distal sections 482, 484. Transversecontour 486 may be configured to receive the volar-distal rim 488 of theradius (see FIG. 19). The perimeter of distal anchor portion 454 may beshaped to correspond generally to the outline of the distal radius. Forexample, the distal-lateral perimeter 490 of the distal anchor portion454 may be more angular and the distal-medial perimeter 492 morerounded.

FIG. 18 shows bone plate 450 and particularly pivotable joint 456 in anexploded view. The pivotable joint may include semi-spherical surfaces502, 504 of the proximal and distal anchor portions 452, 454,respectively. These semi-spherical surfaces may be complementary so thatthey can slide on each other about three orthogonal axes. A retainer 506may include a semi-spherical cavity 508 so that the retainer can bereceived by a second semi-spherical surface 510 of the proximal anchorportion 452. A fastener 512, such as a screw, may be placed through theretainer and proximal anchor portion 452 and into threaded engagementwith a threaded bore 514 of distal anchor portion 454. The fastener maybe turned in opposing directions to provide adjustable and fixedconfigurations of the bone plate. In some embodiments, joint 456 maypermit pivotal movement about one or two axes and/or may permittranslational movement, as described elsewhere the present teachings.The relative disposition of anchor portions 452, 454 may be adjustedwith a tool that engages one or both of the portions, such as in one ormore of the openings of the plate.

FIG. 19 shows bone plate 450 disposed on the volar surface of distalradius 530. Proximal anchor portion 452 may be secured to proximal boneregion 532, and distal anchor portion 454 to distal bone region 534.Pivotable joint 456 may be disposed adjacent a distal facture 536 of thebone. Distal anchor portion 454 may extend over volar-distal rim 488 sothat styloid process 538 may be secured to distal anchor portion 454using a fastener placed in opening 476. Accordingly, a styloiddiscontinuity 540 (such as a fracture) may be spanned by distal anchorportion 454. The outer surface of the bone plate may be longitudinallyconcave and the inner surface longitudinally convex, as shown here, tofollow the contour of the volar surface of the distal radius.

The disclosure set forth above may encompass multiple distinctinventions with independent utility. Although each of these inventionshas been disclosed in its preferred form(s), the specific embodimentsthereof as disclosed and illustrated herein are not to be considered ina limiting sense, because numerous variations are possible. The subjectmatter of the inventions includes all novel and nonobvious combinationsand subcombinations of the various elements, features, functions, and/orproperties disclosed herein. The following claims particularly point outcertain combinations and subcombinations regarded as novel andnonobvious. Inventions embodied in other combinations andsubcombinations of features, functions, elements, and/or properties maybe claimed in applications claiming priority from this or a relatedapplication. Such claims, whether directed to a different invention orto the same invention, and whether broader, narrower, equal, ordifferent in scope to the original claims, also are regarded as includedwithin the subject matter of the inventions of the present disclosure.

We claim:
 1. A method of clavicle fixation, the method comprising:selecting a pre-assembled bone plate including a first plate member anda second plate member connected to one another at a joint having (a) anadjustable configuration in which an orientation of the first platemember and the second plate member relative to one another is adjustableabout an axis normal to a plane defined by the bone plate and (b) afixed configuration in which the orientation is fixed, wherein the jointincludes a threaded fastener that is rotatable to change the joint fromthe adjustable configuration to the fixed configuration; and securingthe bone plate to a clavicle.
 2. The method of claim 1, furthercomprising a step of adjusting the orientation of the first plate memberand the second plate member relative to one another.
 3. The method ofclaim 2, wherein the step of adjusting the orientation of the firstplate member and the second plate member relative to one another isperformed after the step of securing the bone plate to a clavicle. 4.The method of claim 2, wherein the step of adjusting the orientation ofthe first plate member and the second plate member relative to oneanother includes a step of manipulating a tool that is removablyconnected to at least one of the plate members.
 5. The method of claim2, further comprising a step of placing the joint in the fixedconfiguration about the step of adjusting the orientation of the firstplate member and the second plate member relative to one another.
 6. Themethod of claim 1, wherein the orientation is adjustable about only asingle axis.
 7. The method of claim 1, wherein the step of securingincludes a step of placing a plurality of fasteners through openingsdefined by each plate member and into the clavicle.
 8. A method ofclavicle fixation, the method comprising: selecting a pre-assembled boneplate including a first plate member and a second plate member connectedto one another at a joint; moving the first plate member and the secondplate member relative to one another at the joint, to change anorientation of the first plate member and the second plate memberrelative to one another about an axis normal to a plane defined by thebone plate, wherein the step of moving includes a step of manipulating atool that is connected removably to at least one of the plate members;and securing the bone plate to a clavicle.
 9. The method of claim 8,wherein the joint has (a) an adjustable configuration in which theorientation of the first plate member and the second plate memberrelative to one another is adjustable and (b) a fixed configuration inwhich the orientation is fixed.
 10. The method of claim 8, furthercomprising a step of placing the joint in a fixed configuration afterthe step of moving the first plate member and the second plate memberrelative to one another at the joint.
 11. The method of claim 8, whereinthe step of moving the first plate member and the second plate memberrelative to one another at the joint is performed before the step ofsecuring the bone plate to the clavicle.
 12. The method of claim 8,wherein the step of moving the first plate member and the second platemember relative to one another at the joint is performed after the stepof securing the bone plate to the clavicle.
 13. The method of claim 8,wherein the orientation of the first plate member and the second platemember relative to one another is adjustable about only a single axis.14. The method of claim 8, wherein the step of securing includes a stepof placing a plurality of fasteners through openings defined by eachplate member and into the clavicle.
 15. A method of clavicle fixation,the method comprising: selecting a pre-assembled bone plate including afirst plate member and a second plate member connected to one another ata joint; adjusting an orientation of the first plate member and thesecond plate member relative to one another at the joint about an axisnormal to a plane defined by the bone plate; and securing the bone plateto a clavicle.
 16. The method of claim 15, wherein the step of adjustingan orientation of the first plate member and the second plate memberrelative to one another is performed after the step of securing the boneplate to a clavicle.
 17. The method of claim 15, further comprising astep of placing the joint in a fixed configuration about the step ofadjusting an orientation of the first plate member and the second platemember relative to one another.
 18. The method of claim 15, wherein theorientation of the first plate member and the second plate memberrelative to one another is adjustable about only a single axis.
 19. Themethod of claim 15, wherein the step of securing includes a step ofplacing a plurality of fasteners through openings defined by each platemember and into the clavicle.
 20. The method of claim 19, wherein thefasteners are bone screws.